| Primary Device ID | 00887919091608 |
| NIH Device Record Key | 363a5fa1-8063-4a5f-b4de-45c890cc57c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TWIST DRILLS |
| Version Model Number | KM166-310-23S |
| Company DUNS | 082080136 |
| Company Name | Peter Brasseler Holdings, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887919091608 [Primary] |
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
[00887919091608]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-28 |
| Device Publish Date | 2025-03-20 |
| 00887919091622 | KM166-310-25S |
| 00887919091721 | KM166-310-37S |
| 00887919091608 | KM166-310-23S |